Cleared Traditional

K142282 - HUMMINGBIRD(TM) TYMPANOSTOMY TUBE SYSTEM (TTS)

K142282 is an FDA 510(k) clearance for HUMMINGBIRD(TM) TYMPANOSTOMY TUBE SYSTE..., manufactured by Preceptis Medical. The device is a Class 2 Ear, Nose, Throat device with product code ETD cleared through the Traditional 510(k) pathway after a 251-day FDA review.

K142282 · Preceptis Medical · Ear, Nose, Throat device
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Apr 2015
Decision
251d
Days
Class 2
Risk

K142282 is an FDA 510(k) clearance for the HUMMINGBIRD(TM) TYMPANOSTOMY TUBE SYSTEM (TTS). Classified as Tube, Tympanostomy (product code ETD), Class II - Special Controls.

Submitted by Preceptis Medical (Plymouth, US). The FDA issued a Cleared decision on April 23, 2015 after a review of 251 days - an extended review cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.3880 - the FDA ear, nose and throat device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ear, Nose, Throat review framework, consistent with the majority of Class II 510(k) submissions.

View all Preceptis Medical devices

FDA 510(k) Submission Details - K142282

510(k) Number K142282 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 15, 2014
Decision Date April 23, 2015
Days to Decision 251 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
161d slower than avg
Panel avg: 90d · This submission: 251d
Pathway characteristics
Predicate-based equivalence.

ETD Device Classification - Class 2, Special Controls

Product Code ETD Tube, Tympanostomy
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.3880
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Ear, Nose, Throat devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT02165384 Completed Interventional Industry-sponsored

Hummingbird TTS Ear Tube Delivery Study

Continued Evaluation of the Preceptis Medical, Inc. Tympanostomy Ear Tube Introducer

199
Patients (actual)
4
Sites
Treatment
Purpose
Open label
Masking
Condition studied Otitis Media
Study design Single group
Eligibility All sexes · 6 Months+
Principal investigator Frank Rimell, MD
Sponsor Preceptis Medical, Inc. (industry)
Started 2014-01-01 → Primary completion 2018-03-01
Primary outcome
Percentage of Ears in Which an Ear Tube Was Successfully Delivered Across the Tympanic Membrane
View full study on ClinicalTrials.gov

Regulatory Peers - ETD Tube, Tympanostomy

All 89
Devices cleared under the same product code (ETD) and FDA review panel - the closest regulatory comparables to K142282.
TULA Tube Delivery System
K171239 · Tusker Medical · Jun 2017
Hummingbird Tympanostomy Tube
K151830 · Preceptis Medical · Sep 2015
Ventilation (Tympanostomy) Tubes
K151067 · Medtronic Xomed, Inc. · Jul 2015
PRECEPTIS TYMPANOSTOMY TUBE INSERTER
K133921 · Preceptis Medical · Aug 2014
ACCLARENT TYMPANOSTOMY TUBE AND TYMPANOSTOMY TUBE DELIVERY SYSTEM
K103595 · Acclarent, Inc. · Apr 2011
TYMPANOSTOMY TUBE
K082188 · Acclarent, Inc. · Sep 2008